Information:
Error:
ID
29538
Description
Study ID: 102871 Clinical Study ID: HZC102871 Study Title:HZC102871: A 52-week efficacy and safety study to compare the effect of three dosage strengths of Fluticasone Furoate/GW642444 Inhalation Powder with GW642444 on the Annual Rate of Exacerbations in Subjects with Chronic Obstructive Pulmonary Disease (COPD) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01009463 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: fluticasone furoate Trade Name: Veramyst,Avamys,Allermist Study Indication: Pulmonary Disease, Chronic Obstructive Documentation part: Liver Events
Keywords
Versions (2)
- 3/15/18 3/15/18 -
- 4/5/18 4/5/18 -
Copyright Holder
GlaxoSmithKline
Uploaded on
April 5, 2018
DOI
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License
Creative Commons BY-NC 3.0
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GSK Efficacy and safety of Fluticasone on the Annual Rate of Exacerbations in Subjects with Chronic Obstructive Pulmonary Disease (COPD) NCT01009463
Similar models
Liver Events
- StudyEvent: ODM
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
liver event
Item
Is this liver event a serious adverse event?
boolean
C1556667 (UMLS CUI [1])
Item
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping/ interruption criteria?
integer
C0232741 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,3])
C0008000 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,3])
Code List
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping/ interruption criteria?
CL Item
ALT (alanine aminotransferase) (1)
CL Item
AST (aspactate aminotransferase) (2)
CL Item
Total bilirubin (3)
CL Item
Alkaline phosphatase (4)
CL Item
nucleotidase (5)
CL Item
Gammaglutamyltranspeptidase (6)
CL Item
Other (7)
subject age
Item
Is the subject age 55 or older?
boolean
C0001779 (UMLS CUI [1])
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not applicable (3)
diagnostic imaging tests of the liver or hepatobiliary system
Item
Were any diagnostic imaging tests of the liver or hepatobiliary system performed (such as liver ultrasound, computerised tomography or CAT scan, magnetic resonance imaging or MRI, or endoscopic retrograde cholangiopancreatography, or other)?
boolean
C0011923 (UMLS CUI [1,1])
C1711359 (UMLS CUI [1,2])
C0023884 (UMLS CUI [1,3])
C1711359 (UMLS CUI [1,2])
C0023884 (UMLS CUI [1,3])
diagnostic imaging tests of the liver or hepatobiliary system results
Item
If Yes, were the results normal?
boolean
C0011923 (UMLS CUI [1,1])
C1711359 (UMLS CUI [1,2])
C0023884 (UMLS CUI [1,3])
C1711359 (UMLS CUI [1,2])
C0023884 (UMLS CUI [1,3])
liver biopsy
Item
Were any liver biopsies performed?
boolean
C0193388 (UMLS CUI [1])
use of supplements or alternative medicines
Item
Does the subject use herbals, complementary or alternative medicines, food supplements (vitamins) or illicit drugs?
boolean
C0002346 (UMLS CUI [1,1])
C0242295 (UMLS CUI [1,2])
C0281875 (UMLS CUI [1,3])
C0242295 (UMLS CUI [1,2])
C0281875 (UMLS CUI [1,3])
dietary change
Item
Did the subject fast or undergo significant dietary change in the past week?
boolean
C3671772 (UMLS CUI [1])
Item
When did the liver event occur?
integer
C1556667 (UMLS CUI [1,1])
C2745955 (UMLS CUI [1,2])
C2745955 (UMLS CUI [1,2])
CL Item
During the treatment period (1)
CL Item
After the treatment period (2)
Start Date Investigational Product
Item
Start Date Investigational Product
date
C0304229 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
End Date Investigational Product
Item
End Date Investigational Product
date
C0304229 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
Item Group
Pharmacokinetics (Liver PK)
C0031327 (UMLS CUI-1)
C0232741 (UMLS CUI-2)
C0008000 (UMLS CUI-3)
C0232741 (UMLS CUI-2)
C0008000 (UMLS CUI-3)
pharmacokinetic blood sample
Item
Was a pharmacokinetic blood sample obtained?
boolean
C0005834 (UMLS CUI [1,1])
C0031328 (UMLS CUI [1,2])
C0031328 (UMLS CUI [1,2])
date sample taken
Item
If Yes, date sample taken
date
C1302413 (UMLS CUI [1])
time sample taken
Item
If Yes, time sample taken
time
C1277698 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
date of last investigational product dose
Item
If Yes, date of last investigational product dose prior to PK sample
date
C0304229 (UMLS CUI [1,1])
C1762893 (UMLS CUI [1,2])
C1762893 (UMLS CUI [1,2])
time of last investigational product dose
Item
If Yes, time of last investigational product dose prior to PK sample
time
C0304229 (UMLS CUI [1,1])
C1762893 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C1762893 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
date of last medication dose
Item
If Yes, date of last medication dose prior to PK sample
date
C0013227 (UMLS CUI [1,1])
C1762893 (UMLS CUI [1,2])
C1762893 (UMLS CUI [1,2])
time of last medication dose
Item
If Yes, time of last medication dose prior to PK sample
time
C0013227 (UMLS CUI [1,1])
C1762893 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C1762893 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Medication name
Item
Medication: Insert drug name
text
C2360065 (UMLS CUI [1])
Item Group
Liver Disease Medical Conditions
C0023895 (UMLS CUI-1)
C0262926 (UMLS CUI-2)
C1556667 (UMLS CUI-3)
C0262926 (UMLS CUI-2)
C1556667 (UMLS CUI-3)
CL Item
current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
CL Item
current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
CL Item
current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
CL Item
current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item
Epstein Barr Virus Infectious Mononucleosis
integer
C0021345 (UMLS CUI [1,1])
C0014644 (UMLS CUI [1,2])
C0014644 (UMLS CUI [1,2])
CL Item
current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
CL Item
current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
CL Item
current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
CL Item
current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
CL Item
current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
CL Item
current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
CL Item
current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
CL Item
current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item
Gallbladder disease
integer
C0016977 (UMLS CUI [1])
C3275124 (UMLS CUI [2])
C3275124 (UMLS CUI [2])
CL Item
current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
CL Item
current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
CL Item
current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item Group
Other Medical Conditions
C0262926 (UMLS CUI-1)
C0009488 (UMLS CUI-2)
C0009488 (UMLS CUI-2)
CL Item
current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
CL Item
current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
CL Item
current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
CL Item
current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
CL Item
current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
CL Item
current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
CL Item
current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
CL Item
current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item Group
Alcohol intake at onset of Liver Event
C0001948 (UMLS CUI-1)
C1556667 (UMLS CUI-2)
C1556667 (UMLS CUI-2)
alcohol consumption
Item
Does the subject consume alcohol?
boolean
C0001948 (UMLS CUI [1])
average number or units of alcohol consumed per week
Item
Yes, record the average number or units of alcohol consumed per week
float
C0001948 (UMLS CUI [1,1])
C0560579 (UMLS CUI [1,2])
C0560579 (UMLS CUI [1,2])